04/04/2019

04/04/2019 “Start2Pharma: Validation Fundamentals: Equipment & system qualification” in Dutch

04/04/2019 8:30 am - 5:00 pm

Validation Fundamentals: Equipment & system qualification

1. Goal of the training

This course is designed to explain why regulatory agencies require Validation, as well as the consequences of failing to validate processes & systems.  Attendees will gain a broad general background in validation and in addition also the practical application of equipment and system qualification.  The course will provide a walk through the different general steps in validation, the concrete steps for qualifying equipment/ systems, the qualification methods and the “key deliverables”.  After the training the trainees can apply a basic structure for the necessary qualification documents (protocols/report) and document in a correct way.

2. Regulations considered

FDA 21 CRF, FDA guidance on process validation, EU V4 Annex15, EU V4 Chapter 4: Documentation

3. Added value

Practical training given by experts with experience in various domains. The participants will gain sufficient background and tools to work with. A come back session is planned to discuss the trainee experiences in the field.

Learning Objectives

At the end of the course participants will be able to

  • Understand the concepts of Validation
  • Understand why validation is important to the product quality & regulations
  • Understand the whole validation approach from VMP to different types of validation
  • Apply the different steps in V-cycle for equipment/system qualification
  • Understand the main roles in a validation project
  • Understand hot topics like QRM, ASTM & QBD
  • Practice basic change analyses & write rationales
  • Practise basic user requirements analyses
  • Practise good documentation in validation
  • Practise basic validation tasks
  • Know what is expected from them on a first junior validation mission
Scope

Basic validation course containing general concepts + specifics on equipment/system qualification Pharma & life science

 Not in scope but foreseen in other modules:

  • Technical writing skills
  • Advanced QRM
  • Advanced ASTM
  • Process validation, QDB and In process controls
  • QC method / equipment
Methodology
  1. Theoretical knowledge
  2. Exercise through workshops
  3. InterVision day to practice work-related examples

Program
  1. What and why validation
  2. Types of validation
  3. Short Introduction to process validation
  4. Quality by Design
  5. Extended introduction in qualifying for equipment/systems:
    • Steps in the Validation Life Cycle: V-Model/ASTM
    • Validation plan and URS
    • Quality Risk Management
    • Project management for qualification:
    -Approach
    -Several steps and high level timelines/milestones
    -Stakeholder management
    -Roles and responsibilities (RACI)
    -Work with suppliers
    • Protocols/reports/procedures
    -Templates & structure in the different documents
    -Good Documentation Practices
    • Change Control, Quality review and VMP (validation master plan)
    • Roles and responsibilities

Ticket Type Price Spaces
Early Bird Ticket €525.00


Practical information

Trainer: Niek De Schouwer
When: 04/04/2019: 8.30h – 17.00h
Where: Antwerp, Blue Point, Filip Williotstraat 9

This course will be provided in ENGLISH

Price per day: 750 €/excl. VAT

Discount possible:

  • 30 % discount for early birds  (subscription before 30th of  March 2019)
  • Until 50% discount through KMO portfolio or training vouchers (DV.O218731)
  • Full reimbursement through Co-valent : https://www.co-valent.be/
  • 50% discount for students and PHD’s

Parking spots can be found: https://www.mechelen.be

Audience

Pharma professionals who need a background in validation fundamentals or starting in validation projects.

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